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. 2024 Feb 5:4:100064.
doi: 10.1016/j.jhlto.2024.100064. eCollection 2024 May.

Impact of HeartWare ventricular assist device discontinuation on the pediatric population: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry analysis

Robert A Niebler  1 , Muhammad Shezad  2 , Mohammed Absi  3 , Othman A Aljohani  4 , Shahnawaz Amdani  5 , Scott Auerbach  6 , David W Bearl  7 , Katerina Boucek  8 , Holger Buchholz  9 , Chesney Castleberry  10 , John Dykes  11 , Kevin Engelhardt  12 , Joshua Friedland-Little  13 , Kyle Hope  14 , Mehreen Iqbal  15 , Aamir Jeewa  16 , Anna Joong  17 , Angela Lorts  2 , Lindsay May  18 , Deepa Mokshagundam  19 , Deipanjan Nandi  20 , Matthew O'Connor  21 , John J Parent  22 , David M Peng  23 , Natalie Shwaish  24 , Svetlana B Shugh  25 , Christina VanderPluym  26 , Gabrielle Vaughn  27 , Mattew Zinn  28
Affiliations

Impact of HeartWare ventricular assist device discontinuation on the pediatric population: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry analysis

Robert A Niebler et al. JHLT Open. .

Abstract

Background: The HeartWare ventricular assist device (HVAD) was discontinued in July 2021. The study aims to describe the impact the discontinuation the HVAD had on pediatric ventricular assist device (VAD) utilization and outcomes.

Methods: The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry was queried for type of VAD utilization and outcomes/adverse event rates in patients with a body surface area of 0.7 to 1.4 m2. Results were compared from before and after July 2021. All patients in the registry implanted with an HVAD were reported to determine overall outcomes of these patients and define who remains on the device.

Results: The HeartMate 3 (HM3) primarily replaced the HVAD in pediatric patients increasing from 29 of 258 (11%) of implants before July 2021 to 31 of 109 (29%) of implants after. A small increase in the use of the Berlin Heart EXCOR (40 of 258, 16% before to 20 of 109, 18% after) and paracorporeal continuous flow devices (116 of 258, 45% before to 58 of 109, 53% after) was also observed. The rate of ischemic stroke increased in the overall population and a decrease in bleeding complications in the EXCOR group was observed. Of the 187 pediatric patients implanted with an HVAD in the registry, 7 patients remain supported, 1 patient transitioned from the HVAD to an HM3, and 6 patients were lost to follow-up.

Conclusions: The HM3 has been the primary replacement for the HVAD in the medium-sized pediatric population. The rate of ischemic stroke was higher after July 2021.

Keywords: complications; heart failure; mechanical circulatory support; pediatric; ventricular assist device.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Robert A. Niebler reports administrative support and statistical analysis were provided by ACTION Learning Network. David Peng reports a relationship with Berlin Heart of North America that includes funding grants. Robert Niebler reports a relationship with Berlin Heart of North America that includes travel reimbursement. Svetlana B. Shugh reports a relationship with AbioMed Inc. that includes consulting or advisory. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. This work was supported by the ACTION Learning Network. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Figures

Fig. 1
Figure 1
Distribution of device use in pediatric patients with body surface area 0.7 to 1.4 m2 before and after the discontinuation of the HeartWare ventricular assist device. HVAD, HeartWare ventricular assist device.
See this image and copyright information in PMC

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